DESCRIPTION: Once cancer is diagnosed in a patient, surgical intervention is common to remove the malignant tumor. There are few clinical tests that can help physicians decide after surgery whether residual cancer cells remain in the body, and more importantly, whether these cells are inconsequential or aggressive and life-threatening. The chance of cancer- free survival of patients with organ-confined prostate cancer can be excellent. A reliable clinical test that indicates whether prostate cancer cells have spread to secondary sites prior to radical prostatectomy will be a valuable tool for the attending physician. The test will help the physician choose the best treatment options for prostate cancer patients. In this application, a novel clinical test that detects, measures quantitatively and characterizes prostate cancer cells circulating in a patients's blood is described. The test is the Works Prostate Cancer Circulating Cell (CC) Test. The investigators seek sufficient data to launch the commercialization and propose to demonstrate a link between circulating cells and prostate cancer risk. In Phase I, the applicants will focus on additional characterizations of the prostate cancer cells in circulation and will verify the effect of already approved chemo/hormonal treatments on the number and characteristics of circulating prostate cancer cells as related to final patient outcome. The objective is to provide the necessary information to determine the individual patient's responsiveness or nonresponsiveness to the specific chemo/hormonal treatment so that the maximum drug efficacy can be obtained for the individual patient based upon the number of circulating prostate cells as an outcome parameter. The applicants propose to use the test as a surrogate response marker in drug development studies as well. PROPOSED COMMERCIAL APPLICATION: Commercial application of this research could be far reaching since the information gained regarding number and characteristics of circulating prostate cancer cells can be useful for the drug company developing drugs, the physician providing therapy and the quality of life for the patient.